SPO Mechanical Technician

Job Description

The Sterile and Packaging Operations Technician is accountable for performing all preventative and corrective maintenance support for formulation, primary filling, inspection, and/or packaging equipment within their area of assignment for the start-up vaccine manufacturing facility at the West Point, Pa Site.  This position will also be accountable for providing shop floor operations and environmental monitoring support to their area of assignment.  This position will be an individual contributor and member of the Operations team within the Vaccines integrated process team.

This will be a hybrid role focused on startup and future routine operation of the pod vaccine manufacturing facility.  The role will be accountable for ensuring that Environmental Health and Safety and GMP compliance is maintained for their area of assignment.  

This role will also be accountable for troubleshooting and problem-solving equipment related issues and ensuring 100% PM compliance within their area of assignment.

Responsibilities

Delivery

• Set up, adjust, repair, and maintain vaccines formulation, primary filling, inspection, and packaging equipment within the pod vaccine manufacturing facility

• Execute and develop preventative maintenance for vaccine processing and packaging equipment

• Conduct corrective maintenance and troubleshooting for vaccine processing and packaging equipment utilizing diagnostic equipment and programmable logic controllers as necessary

• Partner with operators to execute manufacturing operations tasks within the pod vaccine manufacturing facility

• Use technical information, drawings, diagrams, and schematics to aid in equipment maintenance troubleshooting and repairs

• Disassemble and inspect parts and equipment to determine the cause of improper operation | Make repairs using replacement parts and machine fabrications | Reassemble equipment with new or repaired parts

• Minor and major overhauls to vaccine processing equipment by completely disassembling, repairing, and reassembling equipment to proper operation condition

• Assemble and millwright functions in the receipt and installation of new equipment

Compliance

• Accountable for performing work in a safe manner, following identified safety procedures (hazardous work permitting, and using applicable safety equipment/personnel protective equipment

• Implement maintenance and operations functions in accordance with current Good Manufacturing Practices (cGMPs)

• Complete documentation in batch record and/or computerized maintenance management system in accordance with site procedure

• Maintain good housekeeping and 5S in assigned work area

• Adhere to the highest level of data integrity while performing maintenance and operations duties

• Ensure that work and adjustments performed within the pods is properly documented and executed in alignment with change management procedures

• Assist in the investigation, root cause determination, and Corrective Action and Preventive Action implementation for equipment or personnel related compliance discrepancies noted during day to day activities and/or audits | Escalate as per IPT management processes

Cost

• Participate in new equipment installations by interfacing with equipment vendors, recommending spare parts, selecting lubrication, assisting process-project engineers, assisting qualification, and performing initial de-bug for vaccines processing and packaging equipment

• Ensure that startup activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and met

• Closely monitor equipment performance and improve reliability through problem solving and continuous improvement

• Clean and lubricate equipment periodically and perform other maintenance work required to ensure efficient equipment operation

• Determine proper equipment settings, clearances, and set-up standard work and respond effectively to equipment malfunctions to promote optimal productivity with minimal delays or discards

• Recommend continuous improvement, productivity, and capital projects for the IPT

Team

• Assist engineers and equipment vendors in new equipment installation including completion of qualification documentation

• Provide technical and GMP guidance to outside contractors when they are performing work on process equipment

• Act as liaison to the Utilities maintenance and Calibration teams

• Maintain a culture of continuous improvement and focused on standard work,